Taiwan FDA registration a78c0bd454bb5546c95e94b0abacf3ff

"Upspectrum" medical image transmission device (unsterilized)

TW: "上譜"醫學影像傳輸裝置 (未滅菌)

Taiwan·Risk Class 1·3SHAPE POLAND SP. Z O.O.·Registered Oct 18, 2012 – Oct 18, 2022Cancelled

Registration details

Analysis ID: a78c0bd454bb5546c95e94b0abacf3ff
Customs Code: DHA04401227101

Company information

Manufacturer: 3SHAPE POLAND SP. Z O.O.
Manufacturer Country: Poland
Authorized Representative: SMILDEN BIOTECHNOLOGY CO., LTD.

Product details

Intended Use: Limited to the first-level recognition range of medical image transmission devices (P.2020) of the Measures for the Administration of Medical Devices.
Product Type (Level 1): P Radiology Science
Product Type (Level 2): P.2020 Medical imaging communication devices
Import Information: import

Dates and status

Registration Date: Oct 18, 2012
Expiry Date: Oct 18, 2022
Cancellation Date: Apr 12, 2024

Cancellation information

Status: Logged out
Reason: 許可證已逾有效期

About this record

Access comprehensive regulatory information for "Upspectrum" medical image transmission device (unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number a78c0bd454bb5546c95e94b0abacf3ff and manufactured by 3SHAPE POLAND SP. Z O.O.. The authorized representative in Taiwan is SMILDEN BIOTECHNOLOGY CO., LTD..

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